325 – Regulatory Review Issues for Medical Devices and Diagnostics
Quality Statistical Review Checklist of Investigational Device Exemption (IDE) Submissions for Therapeutic and Aesthetic Medical Devices
Greg Campbell
FDA
Lilly Yue
FDA
An Investigational Device Exemption (IDE) is an application that a sponsor or medical device company makes to FDA to allow for the conduct of a clinical trial using an unapproved medical device for which the device could pose significant risk. This presentation will address the quality components of a statistical review by the Food and Drug Administration (FDA) for such an application in the case when the device is either therapeutic or aesthetic. Such an IDE application includes the specification of the hypotheses to be tested, the evaluation of the protocol and, for a pivotal clinical study, a sample size calculation and reasonableness of its assumptions. In many cases there should also be a Statistical Analysis Plan that includes the primary analysis, the plan for how to handle missing data and how the data are to be submitted electronically. Special considerations for adaptive design
